1. Field of the Invention
The present invention is directed to pharmaceutical formulations comprising agents capable of inhibiting interleukin-1 (IL-1), and to methods for making and using such formulations. The invention is directed to pharmaceutical formulations having increased stability.
2. Statement of Related Art
Interleukin-1 (IL-1) antagonists capable of blocking or inhibiting the biological action of IL-1, have been described. An example IL-1 antagonist, an IL-1 trap, is described in U.S. Pat. No. 6,927,044, herein specifically incorporated by reference in its entirety. The term “IL-1 trap” refers to an IL-1-binding fusion protein comprising a dimer of two fusion proteins, each having two IL-1 receptor components and a multimerizing component.
Lyophilization (freeze-drying under controlled conditions) is commonly used for long-term storage of proteins. The lyophilized protein is substantially resistant to degradation, aggregation, oxidation, and other degenerative processes while in the freeze-dried state (see, for example, U.S. Pat. No. 6,436,897).